Label: MAXIMUM-H- hydrocortisone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 65588-2210-1, 65588-2210-2 - Packager: New GPC, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 13, 2010
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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Inactive ingredients
Water, Petrolatum, Hydrogenated Didecene Cetearyl Alcohol, Ceteareth-20, Lanolin, Mineral Oil, Glycerin, Sorbitan Stearate, Dimethicone, Methylpropanediol, PEG-40 Stearate, Lanolin Alcohol, Esculin, Disodium EDTA, Magnesium Aluminum Silicate, Acrylates/10-30 Alkyl Acrylate, Grosspolymer, 1,2-Hexanediol, Caprylyl Glycol, BHT, Soy, Isoflavones, Sodium Hydroxide, Phenoxyethanol, Sorbic Acid, Menthol, Tricaprylin, Polymethyl Methacrylate, Polyacrylamide, C13-14 Isoparafin, Laureth-7, Citric Acid.
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- WARNINGS
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Directions
Adults and Children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
Children under 2 years of age: Do not use, consult a Doctor.
For hemorrhoids - clean affected area with a cleansing wipe, then dry with a soft cloth. Apply externally to lower part of anal canal only. Apply up to 3 times daily at night and after every bowel movement.
- PRINCIPAL DISPLAY PANEL - 20g Tube Carton
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INGREDIENTS AND APPEARANCE
MAXIMUM-H
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65588-2210 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) EDETATE DISODIUM (UNII: 7FLD91C86K) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) METHYLPROPANEDIOL (UNII: N8F53B3R4R) GLYCERIN (UNII: PDC6A3C0OX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) PETROLATUM (UNII: 4T6H12BN9U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MINERAL OIL (UNII: T5L8T28FGP) LANOLIN ALCOHOLS (UNII: 884C3FA9HE) LANOLIN (UNII: 7EV65EAW6H) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) DIMETHICONE (UNII: 92RU3N3Y1O) TROLAMINE (UNII: 9O3K93S3TK) SOY ISOFLAVONES (UNII: 71B37NR06D) PHENOXYETHANOL (UNII: HIE492ZZ3T) SORBIC ACID (UNII: X045WJ989B) MENTHOL (UNII: L7T10EIP3A) TRICAPRYLIN (UNII: 6P92858988) ESCULIN (UNII: 1Y1L18LQAF) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65588-2210-1 1 in 1 CARTON 1 20 g in 1 TUBE 2 NDC:65588-2210-2 1 in 1 CARTON 2 40 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 12/01/2009 Labeler - New GPC, Inc. (895025443) Establishment Name Address ID/FEI Business Operations New GPC, Inc. 895025443 MANUFACTURE